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Completed

NCT Number: NCT07121205

High-Dose Dual Therapy for H. Pylori Eradication (RETRO-HP Study)

Background:

High-dose dual therapy (HDDT) has emerged as a potential first-line treatment for Helicobacter pylori infection, but its efficacy and safety across different regimens and populations remain unclear. This study aimed to compare real-world outcomes of various HDDT protocols and identify factors influencing treatment failure.

Methods:

A multicenter retrospective analysis was conducted using data from 15 medical centers (January 2022-January 2025). Patients received one of four HDDT regimens: vonoprazan-amoxicillin for 10 days (VA-10) or 14 days (VA-14), esomeprazole-amoxicillin (EA), or tegoprazan-amoxicillin (TA). Primary outcomes included eradication rates (modified intention-to-treat analysis) and adverse events.

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Key information

Conditions

HELICOBACTER PYLORI INFECTIONS

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Gastroenterology, Qilu Hospital of Shandong University, Jinan, Shandong, China.

Jinan, Shandong, Wenhuaxilu, China

About this study

This study is a multicenter, retrospective, observational study utilizing medical records of outpatients who received standard high-dose dual therapy (HDDT) for Helicobacter pylori eradication between January 2022 and January 2025. The aim was to compare the efficacy and adverse event rates of different HDDT regimens.

Collected data included:

Baseline demographics (age, sex, etc.)

Medical/lifestyle history

Treatment regimens

Adverse events

Compliance

All data were anonymized at collection, and no additional patient contact or information collection was required. Since this study involved only retrospective chart review without new interventions, patient consent was waived by the ethics committee.

Treatment Groups

Patients were categorized based on their actual prescribed regimens:

Amoxicillin + Vonoprazan (10-day course)

Amoxicillin + Vonoprazan (14-day course)

Amoxicillin + Tegoprazan (14-day course)

Amoxicillin + Esomeprazole (14-day course)

These groups were compared to assess differences in H. pylori eradication rates.

Study Characteristics No active intervention or real-time questionnaire collection was involved.

Complies with the real-world evidence (RWE) framework for retrospective studies.

Primary Outcome Eradication rate comparison between HDDT regimens (assessed via modified intention-to-treat analysis).

Secondary Outcomes Adverse event rates across different HDDT regimens.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • (1) patients aged 18-70 years, regardless of gender; (2) absent history of receiving H. pylori eradication therapy; (3) diagnosed with H. pylori infection through at least one of the following methods: rapid urease test, ¹³C/¹⁴C-urea breath test, or histopathological examination.

Exclusion criteria

  • (1) patients with incomplete medical records, including missing treatment details, absence of post-treatment follow-up test results, or failure to complete essential follow-up assessments; (2) patients who received treatment regimens that did not conform to the standardized HDDT protocol specified in this study.

Treatment and study plan

This study is a retrospective study, and all data have been collected in advance with no active intervention required.

Other

This study is a retrospective study, and all data have been collected in advance with no active intervention required.

Primary outcomes

  1. Eradication rate

    Time frame: 4-6 weeks

    Comparison of Eradication Rates among Four Different High-Dose Dual Therapies for Helicobacter pylori

  2. Comparison of Eradication Rates Among Four Different High-Dose Dual Therapies for Helicobacter pylori

    Time frame: 4-6 weeks

Secondary outcomes

  1. Adverse Events and Compliance

    Time frame: 4-6 weeks

Sponsors and collaborators

Lead sponsor

Liyueyue

Other

Collaborators

  • Qilu Hospital of Shandong University

Registry information

Official study title

Comparative Analysis of High-Dose Dual Therapies in First-Line Helicobacter Pylori Eradication: A Multicenter Retrospective Study

Acronym: RETROHP

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 13, 2025
Registry last updated
Aug 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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